Identity
- Trade Name
- DRYPIX Plus FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format. FDA UDI
- Model / Reference
- DRYPIX 4000 FDA UDI
- Description
- The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410180077 FDA UDI
- 510(k) Number
- K033377 FDA UDI
- FDA Product Code
- LMC FDA UDI
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic-imaging multiformat camera
DRYPIX Plus by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ACTEON — SOPRO · Class II
- ACTEON — SOPRO · Class II
- ACTEON — SOPRO · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI a3a5db50-c342-4a2e-8a5c-8e85258e4091 36 fields · synced Jun 8, 2026